# K952224: Stryker Constavac Blood Conservation System II (Cbcii)

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Nov 17, 1995 after 189 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: 25 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041525: Hemovac Blood Reinfusion System (2004), 0 descendants of its own

## Recalls of this device
- Nov 12, 2009 · Not classified · Z-0719-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0721-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0722-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0723-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0724-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0727-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0728-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0729-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0730-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0731-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0735-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0737-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0740-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0720-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0725-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0726-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0738-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0739-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0742-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0732-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0736-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0733-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0734-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0741-2010: The product may not be sterile due to package not being intact.
- Nov 12, 2009 · Not classified · Z-0743-2010: The product may not be sterile due to package not being intact.

Source page: https://510kreport.com/device/K952224
Methodology: https://510kreport.com/methodology